Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
What we offer:
Missions
- Provide biomarker expertise and operational guidance to internal and external stakeholders for the successful implementation of the biomarker strategy.
- Responsible for the execution of the biomarker strategy and companion diagnostics, including the planning, coordination and supervision of all operational activities necessary to manage the life cycle of biomarker samples in clinical studies.
- Responsible for the selection of biomarker suppliers in collaboration with the Purchasing and Translational Medicine teams.
- Lead assay development/validation operations and ensure assay preparation in line with clinical sample testing timelines.
- Manage the development and supervision of biomarker assay timelines, budgets, risk management and quality plans.
- Ensure that biomarker sample collection, delivery and analysis are performed in accordance with appropriate quality standards, including ICH/GCP and applicable regulations.
- Work in collaboration with Translational Medicine, Clinical Operations, Clinical Logistics Department, Data Management, Therapeutic Areas, etc.
- Provide operational biomarker expertise in relevant clinical documentation (study protocol, ICF,
- Laboratory Manuals, etc.) and answer regulatory questions.
- Provide education and training in biomarker sample collection and handling to clinical sites and clinical operations teams.
- Contribute to the review of biomarker data and manage queries to sites or CROs to resolve discrepancies in collaboration with Translational Medicine and Data Management departments.
